Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals

Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires that animal drug companies annually report to FDA the amount of antimicrobial drugs they sell or distribute for use in food-producing animals. ADUFA 105 also requires FDA to issue annual summary reports of these sales and distribution data.

In 2014, FDA increased the amount of data included in its annual summary reports. FDA’s annual summary reports currently include additional data tables on the importance of each drug class in human medicine, the approved routes of administration for these antimicrobials, whether these antimicrobials are available over-the-counter or require veterinary oversight, and whether the antimicrobial drug products are approved for therapeutic purposes, or for production purposes or both therapeutic and production purposes. Beginning with their reports covering the period of calendar year 2016, sponsors were required to report estimates of sales and distribution broken out by major food-producing species (cattle, swine, chickens and turkeys).

Why does the FDA collect this information?

With the passage of the Animal Drug User Fee Amendments of 2008, Congress established specific reporting requirements for sponsors (i.e., manufacturers) of antimicrobial animal drugs. Section 105 of that legislation (ADUFA 105) requires such sponsors to annually report to FDA on the amount of each antimicrobial active ingredient in the drug products they sell or distribute for use in food-producing animals.

ADUFA 105 requires animal drug sponsors to list the target animals and production classes specified on the approved labels of the products in their annual reports but does not require them to break out the total sales or distribution data by individual food-animal species. In May 2016, the agency issued a final rule for drug sponsors of antimicrobials sold or distributed for use in food-producing animals which codified the reporting requirements in ADUFA 105 and established a new requirement for such sponsors to provide estimates of sales broken out by major food-producing species (cattle, swine, chickens, and turkeys). Information for each calendar year must be submitted to FDA by March 31st of the following year. In addition, consistent with ADUFA 105, the final rule provides for FDA to continue to prepare and make publicly available annual summaries of this sales and distribution information.

How do the sales and distribution data in this report translate to actual use?

These sales and distribution data only reflect the total quantity of antimicrobial drug product that enters the market, and does not represent how much or in what way these drugs are ultimately used. For instance, veterinarians and animal producers may purchase drugs in anticipation of using them but never actually administer them to animals or they may use them in later years.

What information does the FDA include in the annual summary report?

The report format contains various types of information, including data tables on the importance of each drug class in human medicine, aggregate data on the approved routes of administration for these drug products, as well as information about whether the drug products are available over-the-counter or require veterinary oversight, and whether they are approved for use for therapeutic purposes, or for production purposes or both therapeutic and production purposes. The report also contains sales and distribution information broken down by major food-producing species (cattle, swine, chickens, and turkeys).

Where can I find the FDA’s annual summary reports?

How do the data in FDA’s annual summary reports compare to the estimates of antimicrobial drug sales or distribution data that have been reported by other organizations?

FDA’s annual summary report is not directly comparable to other reported estimates of antimicrobial drug sales or distribution. The summary report includes data on the quantity of antimicrobial drugs sold or distributed for use in all food-producing animal species for all purposes, both therapeutic and non-therapeutic, and includes all dosage forms. Other reported estimates have included different categories of antimicrobials and used different sources of information; thus, they cannot be directly compared to FDA’s annual summary report.

Why are drug sponsors that manufacture and distribute antimicrobial drugs not named in the summary report?

ADUFA 105 requires FDA to summarize sales and distribution data by antimicrobial drug class. As directed by Congress, no individual sponsors are publicly identified in the summary report in order to protect confidential business information. In addition, ADUFA 105 specifies that data from antimicrobial drug classes with fewer than three distinct sponsors only be included in aggregated form in this report.

In the past, there has been speculation that as much as 80 percent of antibiotics sold in the United States are used in food-producing animals. Can you confirm this?

While FDA collects data on antimicrobial drug quantities sold or distributed for use in food-producing animals, we currently do not have data on the actual amount of antimicrobial drugs used in animals in the U.S. or the amount used for specific purposes . FDA and USDA are currently working on strategies for collecting on-farm data on antimicrobial use.

The 80percent figure cited in several media reports and in the November 2017 announcement by the World Health Organization is likely derived from a previous FDA report regarding drug sales, not drug use. Further the 80 percent is likely referring to a comparison of FDA animal antimicrobial drug sales data and Information Management Services Health (IMS Health) human antimicrobial drug sales data.

Before making a direct comparison between the quantity of antimicrobial drugs sold for use in humans and that sold for use in animals, you should consider:

There are many more animals than humans. For instance, there are approximately 320 million people in the U.S., while USDA records indicate that about 9 billion chickens, 32 million cattle, 241,000 turkeys, and 121 million hogs (swine) are slaughtered annually.

There are differences in physiology and weight between humans and animals: the average adult human weighs 182 lbs., while according to USDA data, a chicken weighs approximately 6.2 lbs., a beef steer weighs approximately 1,349 lbs., a turkey weighs approximately 30 lbs., and a hog weighs approximately 282 lbs.

Different species of animals metabolize drugs differently, meaning that some may require more of the drug to be effective, or may need to be treated for a longer period of time.

Of the more than 124 medically important antimicrobial products approved for use in food-producing animals that were actively marketed in 2017, only 11 of these products are approved for use in both food-producing animals and companion animals. With the exception of one tetracycline medicated feed product, the other ten products are approved for use in dogs, cats, and/or horses (in addition to food-producing animals), and collectively represented 138,182 kg of active ingredient domestic sales in 2017. There was a total of 5,562,707 kg of active ingredient domestic sales reported in 2017 for the medically important antimicrobial products. The one tetracycline medicated feed product is approved for use in psittacines (a subset of birds that includes parrots, macaws, and cockatoos), in addition to calves, cattle, chickens, sheep, swine, turkeys and ducks. However, we believe that the use of this product in psittacines is infrequent compared to use in the food-producing animal species. The use of these 11 drug products in companion animals likely has little to no effect on trends in the overall reported sales of antimicrobial drugs.

How much of the recent domestic sales as reported in the 2017 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals is likely attributable to drugs that are exported by distributors without the sponsors’ knowledge?

Antimicrobial animal drug sales and distribution data provided to FDA and summarized in the 2017 Summary Report are only for FDA-approved products labeled for use in the U.S. Although it’s possible that some products included in the domestic sales and distribution data may later be exported by distributors or customers, we don’t believe this to be a usual occurence. Many other countries have their own approval process for animal drugs, so animal producers in these countries would likely be using animal drug products that are approved and specifically labeled for use in their own country.